Linda I. David
15 Providence CT, Groton CT 06340
[Send email to request phone number] 61-2105 cell- [Send email to request phone number] 32-0239 Wk
Email: Linda_970@yahoo.com
EXPERIENCE
2007-Current ExecuPharm, Inc @ Pfizer Inc (CSDM) New London, CT
Clinical Trials Associate: I am currently responsible for maintaining and
coordinating the logistical aspects of clinical trials according to GCP and
relevant SOP’s.
My CTA role is responsible for:
Application of technical knowledge to recognize
problems or delays
Contribution of documentation for trials using external
vendors, and set up activities to facilitate efficient work flow.
Effective development and productive partnerships with
teams and other groups to ensure deliverables meet project
goals and objectives
Execution of assigned tasks to ensure project deliverables
are met.
Identifying and anticipating issues and developing possible
solutions.
Keeping up to date with information and disseminate as
necessary/required liaise with outside vendors as directed to
ensure study deliverables are met
Maintaining study information on a variety of data bases (other than
OC), tracking this information and preparing status reports as required.
Ordering clinical trial supplies
Regulatory compliance of TMF components for clinical
research studies
Review for data inconsistencies within and across
various databases.
Review documents for completeness, accuracy and
compliance with protocol and appropriate regulations
Responsible for ensuring all study documents are
archived based on the appropriate guidelines/policy.
Supporting implementation of technology enabled
processes
Support investigator meeting preparation and
collection/distribution of materials. Liaise between
the centralized group and the Study Manager for
issues and status related to oversight of the IIP
process.
Take appropriate corrective actions to resolve issues
that are identified.
Takes action to prevent or address issues, informs
Study Manager as appropriate. Manage clinical,
regulatory and study-related documents;
Use technical knowledge and experience to work
with the study manager and others as required
proactively
2007 Manpower @ Pfizer Inc (Neurosciences Statistics) Groton, CT
Administrative Partner: I supported the Senior Director of Neurosciences
Statistics as well as his direct reports with:
Coordination: Maintenance: Preparing: Other Duties:
Events (on & offsite)
Training Classes
Monthly Highlights
Recruiting (Candidate
Interview Process)
Calendar
Distribution Lists
Files
Inbox
Insight
Membership Registration/Renewal
Organizational Chart
Telephone Line Ariba Orders
Expense Reports
Travel Collected Contractor Time approval
Composing and Sending Out
Correspondence
Data Entry
Mail pick up and distribution
MSP (viewing candidate resumes and forwarding to the hiring manager)
On/Off boarding
Photocopying & Scanning documents
Uploading Statistical Analysis
Protocols into ELARA
2003-Current Recovery Resources Norwich, CT
Companion: Assisting clients with Acquired & Traumatic Brain Injury with:
Everyday hygiene needs
Keeping detailed records of the client’s daily
actions and activities
Living independent based on their
created protocol Meal Preparation
Medication Administering or Observation of
self administration of medicine by the clients
Transport to appointments or social events
2006 Manpower @ Pfizer Inc (Informatics: AtS PMO Resource Management)
Groton, CT
Purchasing Support Specialist: My role provided a vital service to the AtS
project teams since valid Purchase
Orders are required before contractor onboarding can occur.
My support consisted of:
Assisting in the creation of processes
for this PMO Resource
Creation of Purchase order and
Change order requests
Composing and sending out
Correspondence
Data Entry
Ensuring all Purchase Order
requests were completed
accurately and in a timely manner
as well as the documentation that
came with the request being in the
correct location in eRoom according to
to their status
Faxing, Photocopying and
Scanning documents
Files Maintenance
Liaison between the
PST (Project Support Team)
and MSP (Managed Service
Provider)
Managing the Purchase
Order tracking sheet
On/Off boarding
Management team
The tracking of Purchase Order
progress until Completion
Troubleshoot with PO process
where/when needed
Verification of the documents
Documents being submitted
with the Purchase order request
.
2006 Manpower @ Pfizer Inc (Human Resources-Recruiting)
Groton, CT
Administrative Partner: Supported the Recruiting Manager and her direct reports
with:
Coordination: Maintenance: Preparing: Other Duties:
Assisted with summer
Intern Program
Events (on & offsite)
Recruiting (Candidate
Interview Process)
Calendar
Distribution Lists
Files
Inbox
Job Posting in HR
source
Membership Registration/Renewal
Organizational Chart Ariba Orders
Expense Reports
Travel Composing and Sending
Out Correspondence
Data Entry
Mail pick up and distribution
On/Off boarding
Faxing, Photocopying
and scanning documents
Forwarding applicant resumes
for uploading into our database
2005-2006 Manpower @ Pfizer Inc (Non-Clinical Statistics)
Groton, CT
Administrative Partner: I supported the Senior Director of the Groton
Non-Clinical Statistics group and his direct reports (36 Statisticians) with:
Coordination: Maintenance: Preparing: Other Duties:
Events (on & offsite)
Monthly Highlights
Recruiting (Candidate
Interview Process)
Training Classes
Access Project
Database
Calendar
Distribution Lists
Files
Insight
Membership Registration/Renewal
Organizational Chart
Print Room Ariba Orders
Expense Reports
Monthly Highlights Report
Travel Collected Contractor Timesheets
approval
Composing and Sending out
Correspondence
Data Entry
Mail pick up and distribution
MSP (viewing candidate resume and forward to the hiring manager)
On/Off boarding
Faxing, Photocopying and
scanning documents
Uploading Statistical Analysis
Protocols into ELARA
2003-2005 Bailey Agencies, Inc. (Student Insurance: Claims & Enrollment)
Groton, CT
Account Assistant: I assisted Students with their medical Insurance Enrollment &
Claims. I was in constant contact with students, parents, school administration,
insurance companies, providers, & collection agencies, from six different
colleges, many elementary, middle, & high schools throughout Connecticut. I also
assisted the students, school, & parents in understanding the specifics of their
policy guidelines (Explanation of Benefits), and the payment of their claims.
Accepted & posted the enrollment payments
Assisted the parents, schools, and students how to understand the
specifics of their policy guidelines (Explanation of Benefits) and the payment of
their claims
Challenged Claims Denials
Corrected billing errors Ensured proper documentation was
submitted
for insurance Enrollment & claims processing
Followed up claims progress
Scanned claims into our system
Sent claims out to Insurance companies
Updated student files
EDUCATION:
1993 Ridley-Lowell Business & Technical School
New London, CT
Field of Study: Word Processing Legal. Awards: Dean List &
Perfect Attendance
Classes Included: Accounting, Business Math, Word Processing Legal, Grammar &
Punctuation, Sales & Marketing, Keyboarding, Transcription, and Business
Management.
2003 United Cerebral Palsy for the Department of Mental Retardation
New London, CT
Field of Study: Administration of Medicine and Medical
Terminology
OTHER SKILLS:
I am familiar with Pfizer Applications & Policies. I use: Ariba, GCE/XMS, GDAS
(basic), Outlook, Net Meeting, Get Service, JTS Requests, Right Track II,
eAcess.
Besides the Pfizer experience I can type 70-75 words per minute. I am bilingual
& bicultural. I have attended school both in the United States & Puerto Rico. I
read, write, & speak Spanish fluently. I can translate documents from English to
Spanish & vice versa
|